From: A multi-arm multi-stage clinical trial design for binary outcomes with application to tuberculosis
I =D = culture status | I = culture status,D = relapse | ||||||||
---|---|---|---|---|---|---|---|---|---|
α 1 | Treatment | % stop | Trueθ D | Bias onD | Bias onDafter f/u | Trueθ D | Bias onDafter f/u | ||
arm | at | at interim | Length of f/u | Length of f/u | Length of f/u | Length of f/u | |||
stage 1 | analysis | onI= 4 wks | onI= 8 wks* | onI= 4 wks | onI= 8 wks* | ||||
1 power ω 1 = 90% | |||||||||
0.5 | A | 65 | -5% | -6.9% | -4.7% | -3.2% | -10% | -1.4% | -1.0% |
B | 49 | 0% | -9.5% | -6.5% | -4.6% | -6% | -1.7% | -1.3% | |
C | 23 | 8% | -14.6% | -9.8% | -7.0% | -3% | -2.7% | -1.9% | |
D | 10 | 13% | -18.2% | -12.3% | -8.8% | 0% | -3.0% | -2.1% | |
0.2 | A | 94 | -5% | -0.9% | -0.8% | -0.7% | -10% | -0.2% | -0.2% |
B | 80 | 0% | -2.6% | -2.1% | -1.9% | -6% | -0.5% | -0.5% | |
C | 35 | 8% | -6.9% | -5.9% | -5.0% | -3% | -1.6% | -1.4% | |
D | 10 | 13% | -10.7% | -9.2% | -7.7% | 0% | -2.2% | -2.0% | |
Stage 1 power ω 1 = 95% | |||||||||
0.5 | A | 70 | -5% | -4.6% | -3.6% | -2.8% | -10% | -1.0% | -0.9% |
B | 49 | 0% | -7.3% | -5.6% | -4.5% | -6% | -1.5% | -1.2% | |
C | 17 | 8% | -12.6% | -9.8% | -7.6% | -3% | -2.7% | -2.1% | |
D | 5 | 13% | -16.3% | -12.9% | -9.9% | 0% | -3.4% | -2.7% | |
0.2 | A | 95 | -5% | -0.6% | -0.6% | -0.5% | -10% | -0.2% | -0.2% |
B | 80 | 0% | -2.1% | -1.8% | -1.6% | -6% | -0.5% | -0.4% | |
C | 27 | 8% | -6.7% | -6.0% | -5.3% | -3% | -1.7% | -1.5% | |
D | 5 | 13% | -10.8% | -9.6% | -8.4% | 0% | -2.3% | -2.1% |